Medical Device Certification Specialist jobs in Ontario

What You Can Expect

Responsible for gathering relevant and factual information plus data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and execute projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Quality goals.

This is a hybrid position, 3 days onsite per week.

How You'll Create Impact

• Support improvement of Quality Management Systems (QMS) aligned with international standards and corporate policies.
• Perform Quality Systems maintenance activities including drafting and reviewing SOPs, implementing training programs, providing cross-functional training, and participation in internal audits.
• Assist with Health Canada inspections and corporate / third party audits.
• Monitor and communicate changes in global/local regulatory requirements and international standards; ensure compliance and continuity of business operations.
• Execute product hold workflow from initiation phase through resolution.
• Develop and implement corrective / preventative action plans.
• Perform product and process containment to reduce risks and impact of the nonconformance, utilize root cause analysis tools (e.g. 5 Why, Ishiwaka) and assist with all aspects of investigation, documentation and data collection.
• Support KPI data collection and trending, coordination of management reviews and quality systems reviews.
• Assist with supplier management processes, including new supplier onboarding and approval, supplier monitoring and supplier corrective action plans
• Assist with product complaints, recalls, incident reports, FRNs as necessary.

What Makes You Stand Out

• Knowledge of the Canadian Food and Drugs Act, Canada Medical Device Regulations & Canada CTO regulations.
• Knowledge of ISO 13485:2016 standard.
• Excellent team collaboration and teamwork skills.
• Strong attention to detail; project/submission management skills, ability to multi-task and balance competing priorities.
• Knowledge of overall business environment, the orthopaedic industry, and the marketplace.
• Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, in-vitro diagnostic devices and combination products as needed, based on functional area.
• Ability to build relationships between Quality Assurance and other areas of the organization; ability to communicate effectively at all levels.
• Strong writing, communication, and interpersonal skills.
• Ability to identify risk in business strategies.
• Strong problem-solving skills.
• Effective negotiating skills.

Your Background

• Bachelor’s degree required, science or engineering discipline preferred.
• 0-2 years of relevant experience required.
• Post grad studies or certification in RAQA required.
• Advanced science degree preferred.
• Experience in Regulatory Affairs, Engineering, Quality, or related field considered an asset.
• Certification as a quality engineer (e.g. CQE) or Supplier Quality Profession (CSQP) granted through the American Society of Quality (ASQ), or Certified in Project Management (e.g. CAPM, APM) preferred.
• A combination of education and experience may be considered.

Travel Expectations

Up to 5%

Expected Compensation Range

$55,000 - $65,000 CAD/annual

Holiday and PTO provided

This is a new position